Determining the Feasibility of Spinal Cord Neuromodulation for the Treatment of Chronic Heart Failure

Heart Failure Clinical Trial

— DEFEAT-HF  

Official title:

Determining the Feasibility of Spinal Cord Neuromodulation for the Treatment of Chronic Heart Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01112579
• Other study ID #: DEFEAT-HF
• Status: Completed
• Phase: Phase 2
• First received: April 16, 2010
• Last updated: October 1, 2015
• Start date: April 2010
• Est. completion date: April 2015

Study information

• Verified date: October 2015
• Source: Medtronic Cardiac Rhythm Disease Management
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products AgencySweden: Institutional Review BoardItaly: Ethics CommitteeItaly: Ministry of HealthNetherlands: Ministry of Health, Welfare and SportGermany: Ethics CommissionGermany: Federal Institute for Drugs and Medical DevicesUnited States: Food and Drug AdministrationUnited States: Institutional Review BoardCzech Republic: Ethics CommitteeCzech Republic: State Institute for Drug Control
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the feasibility of spinal cord stimulation (SCS) as a chronic therapy for systolic heart failure.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: April 2015
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Left Ventricular Ejection Fraction (LVEF) of 35 percent or less

• New York Heart Association (NYHA) functional Class III at time of screening

• QRS duration less than 120 milliseconds (ms)

• Left Ventricular End Diastolic Diameter (LVEDD) of 55 millimeters (mm) to 80 mm as determined by echocardiography within the past 6 months

• Receiving stable optimal medical therapy for heart failure prior to enrollment

• Serum creatinine less than or equal to 3.0 milligrams per deciliter (mg/dL)

• 18 years of age or older

• Willing and able to comply with study procedures

• Expected lifespan greater than 12 months beyond study enrollment as assessed by physician

Exclusion Criteria:

• Interruption of thromboprophylaxis (e.g., heparin, LMWH, warfarin, aspirin, dabigatran, clopidogrel) would pose an unacceptable health risk (e.g., patient with an abnormal bleeding time), as determined by physician

• Polyneuropathy

• Requires diathermy including shortwave diathermy, microwave diathermy, or therapeutic ultrasound diathermy

• Unable to perform an exercise capacity test

• Pregnant or planning to become pregnant during this study

• Currently enrolled or plans to enroll in another investigational device or drug study that may confound the results of this study

• Had Coronary Artery Bypass Graft/Percutaneous Coronary Intervention/Bare Metal Stent (CABG/PCI/BMS) procedures within the past 90 days

• Had a heart transplant

• Has complete heart block

• Had Acute Coronary Syndrome within the past 90 days

• Has congenital heart disease with significant hemodynamic shunting

• Has chemotherapy-induced heart failure

• Has reversible cardiomyopathy

• Has severe mitral regurgitation (greater than 60 percent regurgitant fraction or greater than 0.3 centimeters squared (cm2) regurgitant orifice area)

• Has diagnosed unstable angina pectoris

• Has unstable coronary artery disease

• Has a Cardiac Resynchronization Therapy (CRT) device implanted and is receiving CRT therapy

• Has a non-Medtronic Implantable Cardioverter Defibrillator (ICD), pacemaker, or any non-transvenous defibrillation lead

• Has a Medtronic ICD whose sensing threshold cannot be programmed to 0.3mV or greater

• Has an existing neurostimulator

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Failure

Intervention

Device:
• Medtronic PrimeADVANCED Neurostimulator
Heart failure therapy
• Medtronic PrimeADVANCED Neurostimulator
Medical management

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Cardiac Rhythm Disease Management

Countries where clinical trial is conducted

United States,  Canada,  Czech Republic,  Germany,  Italy,  Netherlands,  South Africa,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the Reduction in Left-ventricular End Systolic Volume Index (LVESVi) After 6 Months of Spinal Cord Stimulation (SCS) Therapy in the Treatment Arm Compared to the Control Arm.		Baseline and 6 months	No
Secondary	Characterize the Change in proBNP Between the Treatment Arm and Control Arm Through 6 Months		Baseline and 6 Months	No
Secondary	Characterize the Change in Peak Oxygen Uptake Between the Treatment Arm and Control Arm Through 6 Months		Baseline and 6 Months	No